Pediatric Autism Diagnosis Aid

Helps a primary care clinician reach an autism diagnosis in young children, using caregiver answers, clinician input and video.

6 products cleared under FDA code QPF, from June 2, 2021 to March 5, 2026. Checked September 25, 2026.

The odd one out on this list, and one of the most interesting.

There is no scan for autism. Diagnosis normally means a specialist assessment, and the waiting lists for those run to a year or more in many places. A year is an enormous amount of time in the life of a two year old, because early support works better the earlier it starts.

Software in this device type pulls together answers from caregivers, input from the clinician, and video of the child, and helps a primary care clinician reach a diagnosis rather than only make a referral.

It is cleared as a diagnosis aid. The clinician diagnoses. What changes is where that can happen and how fast.

Clearances per Year

1 2021

1 2022

1 2023

2 2025

1 2026

What the FDA Actually Signed Off On

FDA product code: QPF
FDA name for it: Pediatric Autism Spectrum Disorder Diagnosis Aid
Rule number: 21 CFR 882.1491
Risk class: Class 2
Medical field: Neurology

The FDA's own wording: A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.

Before You Sign Anything

Ask what happens when the software cannot return a result, because a meaningful share of cases will still need the specialist.
Ask what training the clinician needs and who is accountable for the diagnosis.
Ask which age range it is cleared for, and how it performed in girls, who are diagnosed later and less often.

Who Holds the Most Clearances Here

Companies with the most clearances under Pediatric Autism Diagnosis Aid
Company	Cleared products
Earlitec Diagnostics	2
Cognoa, Inc.	2
Earlitec Diagnostics, Inc.	2

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

All 6 products cleared under Pediatric Autism Diagnosis Aid
Product	Company	Cleared	FDA record
EarliPoint Assessment	Earlitec Diagnostics	March 5, 2026	K253442
Canvas Dx	Cognoa, Inc.	April 11, 2025	K243558
EarliPoint System	Earlitec Diagnostics	March 26, 2025	K243891
EarliPoint	Earlitec Diagnostics, Inc.	June 29, 2023	K230337
EarliPoint System	Earlitec Diagnostics, Inc.	June 8, 2022	K213882
Cognoa ASD Diagnosis Aid	Cognoa, Inc.	June 2, 2021	DEN200069

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.